Sue Mann
Sue Mann Consultancy
Referierende
Highlights:
- Background and Regulatory Expectations
- Rethinking “Human Error” – From Blame to System Thinking
- Practical Case Examples
- Rethinking “Human Error” – From Blame to System Thinking
- Practical Case Examples
Zielgruppe
This Live Online Session is designed for professionals involved in evaluating and improving GMP compliance, including QPs and auditors.
Zielsetzung
This training aims to strengthen participants’ ability to differentiate between apparent human error and true root causes in GMP-relevant deviations.
The objective is to enhance investigation quality, avoid premature attribution to “human error,” and ensure that process-, procedural-, or system-related deficiencies are appropriately identified and addressed.
Human error cannot be completely avoided. However, issues that initially appear to be caused by human error should always be explored further. In most cases, human error is not the true root cause of a non-conformance but rather a consequence of an underlying systemic weakness. Nevertheless, the pharmaceutical industry still seems to struggle with recognising and correctly addressing the different types of human error and their true causes, while regulators tend to regard human error only as a last resort. Chapter 1 of the EU GMP Guidelines (1.4, xiv) states: “Where human error is suspected or identified as the cause, this should be justified, having taken care to ensure that process-, procedural- or system-based errors or problems have not been overlooked…”.
The objective is to enhance investigation quality, avoid premature attribution to “human error,” and ensure that process-, procedural-, or system-related deficiencies are appropriately identified and addressed.
Human error cannot be completely avoided. However, issues that initially appear to be caused by human error should always be explored further. In most cases, human error is not the true root cause of a non-conformance but rather a consequence of an underlying systemic weakness. Nevertheless, the pharmaceutical industry still seems to struggle with recognising and correctly addressing the different types of human error and their true causes, while regulators tend to regard human error only as a last resort. Chapter 1 of the EU GMP Guidelines (1.4, xiv) states: “Where human error is suspected or identified as the cause, this should be justified, having taken care to ensure that process-, procedural- or system-based errors or problems have not been overlooked…”.
Programm
Part 1: What is behind “Human Error”?
- Why do we have human error?
- Humans are not machines
- Human error rates – what is acceptable?
- Why human error could not be a root cause
- Is human error avoidable?
Part 2: Examples for deeper Understanding
Analyse real-life scenarios and identify typical investigation weaknesses. Gain practical tips to reduce human error through process design, environment, and system improvements – instead of relying on retraining alone.
Analyse real-life scenarios and identify typical investigation weaknesses. Gain practical tips to reduce human error through process design, environment, and system improvements – instead of relying on retraining alone.
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
Non-ECA Members EUR 690
ECA Members EUR 590
APIC Members EUR 640
EU GMP Inspectorates EUR 590.-
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
Non-ECA Members EUR 690
ECA Members EUR 590
APIC Members EUR 640
EU GMP Inspectorates EUR 590.-
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Thu, 29 Oct 2026, 09:00-12:30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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